The FDA has announced its Safe Use Initiative. The mission of the program is to create and facilitate public and private collaborations within the healthcare community to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with partners who are committed to safe medication use. They are looking to partner with federal agencies, healthcare professionals and professional societies, pharmacies, hospitals, and other health care entities plus patients, caregivers, consumers, and their representative organizations.
It’s a pretty broad initiative and includes many opportunities to improve medication safety. Some specific topics mentioned include reducing the risk of acetaminophen toxicity, reducing surgical fire risk associated with alcohol-based preps, errors related to medication dosing devices, and issues related to medication vials.
FDA Safe Use Initiative
We’ve addressed the issue of perioperative beta blocker use in multiple columns (see Patient Safety Tips of the Week for November 20, 2007 “New Evidence Questions Perioperative Beta Blocker Use” and November 4, 2008 “Beta Blockers Take More Hits”). The American College of Cardiology Foundation and American Heart Association have now updated their ACC/AHA guidelines on perioperative use of beta blockers.
The only remaining Class I recommendation is that beta blockers be continued in patients already taking them for angina, arrhythmias, hypertension or other ACC/AHA class I guideline indications.
The major new recommendation is that routine administration of high-dose beta blockers in the absence of dose titration is not useful and may be harmful to patients not currently taking beta blockers who are undergoing noncardiac surgery.
They also downgraded the levels of supportive evidence for use of perioperative beta blockers in patients in whom preoperative assessment identifies coronary heart disease or high cardiac risk who are undergoing intermediate-risk or vascular surgery (though the recommendations still use the term “probably recommended”).
Note, however, that all the recommendations carefully use the wording “Beta blockers titrated to heart rate and blood pressure”. You’ll recall that critics of the POISE trial attributed the negative influence of beta blockers (stroke and death) to the fact that the beta blockers in that study were not titrated to blood pressure and heart rate.
The perioperative beta blocker controversy is not over yet. Proponents of their use (eg. Poldermans et al 2009) continue to focus on the need for careful titration of dose, timing, specific beta blocker, and issues such as withdrawal of beta blockers. The controversy is not likely to be resolved until a study like POISE is repeated, using that titrated dose approach to perioperative beta blockers.
Fleisher LA, Beckman JA, Brown KA, et al.for the American College of Cardiology Foundation, American Heart Association Task Force on Practice Guidelines, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine, Society for Vascular Surgery. 2009 ACCF/AHA Focused Update on Perioperative Beta Blockade Incorporated Into the ACC/AHA 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Noncardiac Surgery. J. Am. Coll. Cardiol. 2009, first published on Nov 2, 2009 as doi: doi:10.1016/j.jacc.2009.07.010
Poldermans, Don; Schouten, Olaf; van Lier, Felix; Hoeks, Sanne E.; van de Ven, Louis; Stolker, Robert Jan; Fleisher, Lee A. Perioperative Strokes and Beta Blockade. Anesthesiology 2009. 111(5): 940-945, November 2009.
Negative pressure wound therapy (aka “wound vac” or NPWT) has been being used much more frequently in recent years for managing a variety of wounds. There has always been considerable debate about the strength of evidence for its efficacy and the overall cost-effectiveness. All of us, however, have probably seen individual cases of difficult-to-heal wounds that dramatically improved after initiation of negative pressure therapy. But seldom in the debate about wound vac has there been much said about safety issues. Now the FDA has issued a preliminary safety alert about negative pressure wound therapy, based on reports of 6 deaths and 77 injuries reported over the past 2 years. Serious bleeding was the most serious complication. This was seen in patients with vascular grafts, sternal and groin wounds, and patients on anticoagulants. It was often noted during dressing removal where the dressings adhered to tissues. Multiple other reports dealt with infection related to retained dressing pieces.
They list several types of wounds for which NPWT is contraindicated including those with necrotic tissue with eschar present, untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, and those with exposed vasculature, nerves, organs or anastomotic sites.
They also go on to list risk factors that may predispose to these complications and make recommendations about ensuring that the patient and/or caregiver has been appropriately instructed on use of the system and how to recognize and address complications.
You’ve often heard us use the phrase “Stories, Not Statistics”. When we first began doing presentations on patient safety in the early 1990’s we often began with some of the statistics on medical error from Lucien Leape’s work. But we began to notice physicians and medical students begin to zone out when we talked about statistics on medical error. What they liked were the anecdotes we would tell about cases that really happened. So we changed our focus. While we still often show statistics on medical error to put things in context, we no longer highlight them. Instead, we really rely on the stories. That’s what gets people’s attention. That’s what makes people say “I wonder if that could happen here?” and what makes them go back to look at the systems in their health care systems. It is those stories that hit home hard and make people remember. Who cannot remember their own reactions when they first heard the Josie King story, or the story about the nurse who administered Bicillin intravascularly, or the little boy who died from concentrated epinephrine injection during a simple surgical procedure, or any nurse who inadvertently administered concentrated potassium solutions?
In fact, that is one of the reasons we feel that publication by the Institute of Medicine in 2000 “To Err is Human: Building a Safer Health System” has failed to gain traction despite considerable initial media attention. Everyone focused on the statistics from that report. It lacked the stories about real people you need to tell in order to get people and systems to change.
Others involved in safety in both health care and other industries have clearly valued the role of stories in promoting safety. See our comments on the work of Gary Klein (May 27, 2008 “If You Do RCA’s or Design Healthcare Processes…Read Gary Klein’s Work”) and Eric Hollnagel (September 15, 2009 “ETTO’s: Efficiency-Thoroughness Trade-Offs”).
Now, the National Patient Safety Agency (UK) has come out with exactly that sort of approach we endorse “National Patient Safety Agency: combining stories with statistics to minimise harm”. That is the first of a series of recommendations that will be published in the British Medical Journal to improve patient safety. They describe how reports and stories of incidents will be used to more rapidly call to attention significant patient safety issues. Prior NPSA patient safety alerts often took years of analysis of data before reports were issued. The new approach is a much welcomed one and one that we in the US need to adopt. We have state and national databases replete with lessons learned from patient safety incidents that are sitting there untapped. We don’t need to wait for detailed analysis of statistics to get many of those messages out to our hospitals and health care systems. We tend to wait far too long before we disseminate the valuable warnings and lessons learned. How many instances of inadvertent administration of concentrated potassium chloride did it take before we got the message out that there was a system solution?
Institute of Medicine. To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press, 2000
Lamont T, Scarpello J. Safety Alerts: National Patient Safety Agency: combining stories with statistics to minimise harm. BMJ 2009; 339: b4489
In our December 1, 2009 Patient Safety Tip of the Week “Patient Safety Doesn’t End at Discharge” we began discussion on the potential role of DVT prophylaxis in outpatients. We noted we do it for patients undergoing a few orthopedic procedures and we noted increased attention to the DVT risks in oncology patients.
Now a major population study has really added some urgency to the question of DVT prophylaxis in ambulatory patients. Analysis done on the UK’s Million Women Study (Sweetland et al 2009) looked at the duration and magnitude of the postoperative risk of venous thromboembolism in middle aged women. They found that the incidence of DVT and pulmonary embolism after surgery is substantially increased in the first 12 postoperative weeks, though the risk varies by type of surgery. Risk was highest in the first 6 weeks post-op, peaking during the 3rd week, but remained high for at least 7-12 weeks post-op. The risks for pulmonary embolism paralleled that for DVT. Major orthopedic surgery and cancer surgery had the highest risks, but the increased risks spanned almost all types of surgery. Most interestingly, even same day surgery was associated with a prolonged risk for DVT. That certainly pours water on the argument that immobility is the biggest DVT risk factor.
While this study is an eye opener, don’t run out there and start anticoagulating all your surgical patients for months at a time. We clearly need prospective randomized trials that demonstrate the benefits of prolonged DVT prophylaxis would outweigh the risks. Such studies would have to include a very large sample size, particularly since it is likely that certain subgroups would have greater or lesser risks and benefits.
Another new review (Spyropoulos et al 2009) looks at issues surrounding DVT prophylaxis in medical patients. It notes that data from large clinical trials support LMWH prophylaxis for up to 14 days in medical patients but that most patients are discharged without such prophylaxis. That paper has a good analysis of the duration of prophylaxis issue and also has great discussions on LMWH vs. unfractionated heparin, proper dosing of unfractionated heparin, mechanical DVT prophylaxis, and special populations (eg. obese or those with renal impairment).
Sweetland S, Green J, Liu B, et al. Duration and magnitude of the postoperative risk of venous thromboembolism in middle aged women: prospective cohort study. BMJ 2009; 339: b4583 (Published 3 December 2009)
Spyropoulos AC, Mahan C. Venous Thromboembolism Prophylaxis in the Medical Patient: Controversies and Perspectives. The American Journal of Medicine 2009; 122(12): 1077-1084
Over the years we have tried to avoid mixing health care policy with patient safety issues. Sometimes that is unavoidable. Our “May 2009 What's New in the Patient Safety World” column touched on several issues that are crucial to health care reform and also impact patient safety. This month we want to point out for you one of the best essays on what is needed in health care reform: David Goldhill‘s article in The Atlantic “How American Health Care Killed My Father”. It is a remarkable businessman’s perspective on the real root causes of our failing health care system and why we can’t fix it without a major structural overhaul. Definitely worth reading.
Goldhill D. How American Health Care Killed My Father. The Atlantic September 2009